Imviva Biotech Presents Validating Data for CAR-T Cell Therapies CTD402 and CTA311 in Five Presentations at the 67th American Society of Hematology Annual Meeting

Key Takeaways:

• Imviva Biotech presented five posters at the 67th American Society of Hematology Annual Meeting.
• CTD402 is a CD7-targeted CAR-T therapy for T-ALL/LBL and severe aplastic anemia.
• CTA311 targets CD19 for patients with relapsed/refractory B-ALL.
• TENACITY-01 (Phase 1b/2) uses a flat dose of 400×10⁶ CAR-T cells supported by standard fludarabine/cyclophosphamide conditioning.
• Preliminary outcomes show the potential for high MRD-negative remission rates and durable responses.

Breaking New Ground in CAR-T Therapies

Imviva Biotech’s latest research into next-generation, allogeneic CAR-T cell therapies was unveiled at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. The company showcased five poster presentations detailing the potential impact of its investigational treatments on multiple hematological malignancies, including both T-cell leukemias and B-cell leukemias.

CTD402: A Transformative Approach to T-Cell Malignancies

Among the highlights was CTD402, a novel CD7-directed therapy under investigation in the Phase 1b/2 TENACITY-01 clinical trial (NCT07070219). This trial enrolls adolescents and adults (aged 12 and up) with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (LBL). Participants receive a standard fludarabine/cyclophosphamide regimen before infusion of CTD402 at a flat dose of 400×10⁶ CAR-T cells. Early data suggest encouraging remission rates, including negative minimal residual disease (MRD) findings, pointing to a new avenue of hope for patients facing limited treatment options.

Expanding Applications to Severe Aplastic Anemia

Further studies presented at ASH explored the potential of CTD402 to treat severe aplastic anemia (SAA)—a life-threatening disorder driven by abnormal T-cell activity. Since standard immunosuppressive therapies can be ineffective in some cases, the findings underlined the importance of novel interventions. CTD402’s CD7-targeted allogeneic approach may offer relief for patients who have exhausted conventional treatments.

CTA311: Targeting B-Cell Malignancies

Imviva Biotech also showcased advancements in CTA311, an allogeneic CAR-T therapy designed to target CD19 for patients diagnosed with relapsed or refractory lymphoblastic leukemia (B-ALL). Like CTD402, CTA311 incorporates T-cell receptor (TCR) and HLA knockout technologies, alongside Imviva’s proprietary ANSWER™ inhibitory ligands. These innovations aim to minimize immune rejection, an essential factor in enabling off-the-shelf therapies to offer meaningful and durable responses.

Innovative Manufacturing and Future Directions

Central to both CTD402 and CTA311’s potential success is Imviva Biotech’s manufacturing innovation. By knocking out TCR and HLA genes and incorporating ANSWER™ inhibitory ligands, the company seeks to reduce the chances of host-versus-graft rejection and improve the long-term persistence of the infused CAR-T cells. As the clinical trials progress, Imviva Biotech intends to evaluate the therapies’ efficacy further, possibly expanding patient eligibility and offering new paths forward for individuals grappling with hard-to-treat conditions.